Compounding the Problem

Harold E. Cohen, RPhEditor-in-Chief

7/20/2009

US Pharm. 2009;34(7):3.

I happened to be in West Palm Beach, Florida, one day a few months ago getting ready to attend a pharmacy conference while, in a neighboring town, members of the Lechuza Caracas (Venezuela) polo team were preparing to take the field in the 105th U.S. Open Polo Championship. I later learned the news that 21 elite polo horses had collapsed before the eyes of astonished spectators. Many of the horses were dead within an hour. Initial autopsy results revealed that several of the animals experienced significant hemorrhaging, but it would take some time for the toxicology results to come back. The deaths were eventually attributed to an overdose of a vitamin compounded by a pharmacy in Ocala, Florida, that specializes in compounding veterinary products. As it turns out, five horses that were not given the drug survived. And while many in the polo community continue to mourn the loss of these well-trained horses, it was a story that lasted only about 3 weeks. But in reality, this is not the end of this story. Unfortunately, the events of that day triggered the FDA to once again become vocal on the risks of pharmacy compounding.

Our profession was built on the principles of compounding. While it is true that the art of compounding has most certainly taken a back seat to the more common pharmacy practice of essentially repackaging manufactured medications, there are still hundreds, if not thousands, of licensed compounding pharmacies in this country that still play a vital role in making sure patients get the medications they need that may not be available from pharmaceutical manufacturers. To be fair, the FDA is in a difficult situation when it comes to compounding by licensed pharmacists. At what point is compounding considered manufacturing? And if it were to be considered manufacturing, should compounding pharmacies undergo the same FDA scrutiny as pharmaceutical manufacturers?

I wonder what the agency's position would have been during the decades before there was an FDA, when virtually every patient in this country took medications that were only compounded by pharmacists. Just because the profession has evolved into something else over the years, should compounding pharmacists be singled out as risks to our health care system? The FDA is walking a tightrope on this one. According to a published FDA Consumer Health Information article titled "The Special Risks of Pharmacy Compounding," the FDA clearly states that while compounding is "a vital service that helps many people," in the same breath it warns consumers that they "need to be aware that compounded drugs are not FDA-approved [which] means that the FDA has not verified their safety and effectiveness." The article goes to great lengths to cite several examples where patients died or suffered from an adverse reaction brought on by a drug that was compounded incorrectly.

I appreciate the FDA's position on compounding, but it seems to cast aspersions on the entire compounding pharmacist community because of a few errors over the years. I agree that the obvious compounding of the same drug in bulk should be treated like manufacturing, but instead of warning the public of the risks involved in compounded medications, how about a little praise for an art that is all but forgotten, yet is one that benefits thousands of patients who might not be able to get therapy anywhere else? The FDA needs to start treating compounding pharmacists with the respect they deserve. If not, the art of compounding and the long history it has with the profession of pharmacy will indeed become extinct. We must not let that happen.

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